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Clinical Trial Associate

Waltham, MA 02459

Posted: 04/25/2022 Industry: Scientific and Life Sciences Job Number: 14308

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

 

Title: Clinical Trial Associate

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Temp-Perm
  • Pay rate: $35-38hr
  • Job Location: Waltham, MA
  • Job#: bh14308

 

Clinical Trial Associate
 

SUMMARY:
The Clinical Trial Associate (CTA) is responsible for assisting and providing support to members of the clinical operations project team (e.g., Clinical Project/Trial Managers) to facilitate the management of clinical trial processes, including planning and execution of in-house or outsourced clinical trials. The CTA assists in supporting the conduct of trials and may be responsible for managing specific study and operational tasks. The CTA performs work according to established protocols and standard operating procedures under general supervision.


RESPONSIBILITIES:

  • Facilitate study start-up tasks including site feasibility and CDA process
  • Collect & collate documents required for EC/IRB/HA submissions
  • Generate and/or review clinical documents and reports, including the first draft of the ICF
  • Develop trackers and reports for study-related activities
  • Track and review essential documents for site activation
  • Initiate investigational product release to sites and track site drug acknowledgments
  • Manage systems access for the study team (e.g., eTMF, CTMS, EDC, IRT)
  • Perform document quality checks; process and submit documents to eTMF
  • Serve as study-specific Administrator for clinical trials application (KPTrial)
  • Assist with preparation for audits/inspections
  • Support SUSAR distribution
  • Maintain internal & external contacts lists
  • Participate in the creation and distribution of specific study aids/materials and site communications
  • Coordinate delivery of clinical trial supplies in collaboration with the clinical supply team
  • Distribute agenda & take minutes for internal study team meetings
  • Manage study-specific PO creation
  • Assist with ClinicalTrials.gov protocol record updates as needed
  • Facilitate study closeout activities including document reconciliation and report preparation
  • May assist with CRA management under the supervision of Clinical Project/Trial Manager
  • Participate in other project activities, as assigned by the Clinical Project/Trial Manager
  • Collaborate with peer CTAs to share knowledge of processes and best practices
  • Participate in inter-departmental workgroups to create and enhance operational processes
  • Pursue career development opportunities and activities as necessary
  • Maintain up to date training records per SOPs, processes, and procedures
  • Up to 10% domestic and/or international travel may be required

 

QUALIFICATIONS:

  • Bachelor's degree or nursing qualification is required. Scientific/health care field
    preferred, but not required
  • Minimum 0-2 years of relevant experience in clinical research (e.g., clinical site, CRO, sponsor, or clinical trial vendor) or related field
  • Adequate Good Clinical Practice training
  • General knowledge of guidelines governing clinical research
  • Comfortable with technology and ability to learn new systems quickly
  • Proficiency with MS Word, Excel, PowerPoint, and Outlook
  • Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
  • Ability to professionally interact and communicate with visitors, vendors, and individuals at all levels of the organization.
  • Capacity to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Ability to work successfully within a cross-functional team

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!

 

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